The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the recall of one batch of Juhel Folic acid 5mg x1000 tablet.
The product was discovered during the Risk Based Post Marketing Surveillance (PMS) sampling in February 2025 and laboratory analysis indicates that the product is substandard.
According to the manufacturer, root cause analysis conducted on the product attributed the issue to low active pharmaceutical ingredient (API) content due to the malfunction of the weight adjuster device in the tableting machine. Therefore, the product was recalled.
Folic acid is used to treat or prevent foliate deficiency anaemia. It helps baby’s brain, skull and spinal cord develop properly in pregnancy to avoid problems such as spina bifida.
Risk Statement
Administering substandard medicines poses significant risks to patient health and public health. These risks include poisoning, treatment failure, drug resistance, and even death. Substandard medicines may contain toxic substances, incorrect ingredients, or incorrect dosages, leading to severe adverse effects
Product details
The details of the affected batches are as follows:
Product Name
| Juhel Folic acid tablet 5mg x1000 |
Product Manufacturer: | Juhel Pharma Ltd. 35, Nkwubor Road Emene – Enugu
|
Lot Number: | 0531 |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard product within the zones and states.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance in the supply chain to prevent the distribution, sale, and use of falsified products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
